Oral Mucositis
Conditions
Keywords
Oral Mucositis, High Level Laser Therapy, Hematopoietic Stem cell Transplant
Brief summary
The goal of this clinical trial is to learn if high-level laser therapy can manage oral mucositis in pediatric patients undergoing hematopoietic bone marrow transplantation. The main question it aims to answer is : Is high-level laser therapy effective as a treatment for oral mucositis in pediatric hemopoietic stem cell transplant patients? Researchers will compare patients receiving basic oral care to see the effect on the WHO oral mucositis scale. Participants will be subjected to high level laser on lesion sites .
Interventions
DEVICEhigh power laser therapy
high power laser therapy once daily for four consecutive days with wavelength 660 to 970 nm, power 3.2 w, and duration of 230 seconds at 50% duty cycle
DRUGBasic oral care
patients will receive local methods: cholorohexidine mouthwash as well sodium bicarbonate mouthwash
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children under the age of 18 years undergoing bone marrow transplantation during the phase of oral mucositis. * Oral mucositis starting from grade II on the WHO scale for OM. * Willingness to undergo treatment for four consecutive days and to return for evaluation 7 and 11 days after enrolment.
Exclusion criteria
* Previous treatment with photobiomodulation for oral mucositis. * Limited mouth opening less than 2 cm. * Presence of dysplastic oral lesions. * Radiotherapy in the head and neck area. * Vulnerable groups of patients or decision-impaired individuals as prisoners, handicapped and mentally retarded individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral mucositis score | at baseline (day 1), day 7, and day 11 from the start of treatment | World Health Organization (WHO) scale of oral mucositis will be used to describe the lesions at baseline, day 7 and day 11, lesions are given grades from 1 to 4, with 4 being a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | at baseline (day 1), day 7, and day 11 from the start of treatment | Pain visual analogue scale will be used to measure pain level, where the patient will be given a diagram representing pain levels from 1 to 10, 10 being the highest level of pain |
Countries
Egypt
Contacts
CONTACTAsmaa Ayman Gabr, Teaching Assistant
Outcome results
None listed